Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2020, 37896-37901 [2019-16434]
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Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Notices
Step Three—Send the payment for
your application as described in section
VIII.A.
Step Four—Please submit your
application and a copy of the completed
Animal Generic Drug User Fee Cover
Sheet to the following address: Food
and Drug Administration, Center for
Veterinary Medicine, Document Control
Unit (HFV–199), 7500 Standish Pl.,
Rockville, MD 20855.
ForIndustry/UserFees/AnimalDrugUser
FeeActADUFA/default.htm or contact
Lisa Kable, Center for Veterinary
Medicine (HFV–10), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–6888,
Lisa.Kable@fda.hhs.gov. For general
questions, you may also email the
Center for Veterinary Medicine (CVM)
at: cvmadufa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
C. Product and Sponsor Fees
By December 31, 2019, FDA will issue
invoices and payment instructions for
product and sponsor fees for FY 2020
using this fee schedule. Fees will be due
by January 31, 2020. FDA will issue
invoices in November 2020 for any
products and sponsors subject to fees for
FY 2020 that qualify for fees after the
December 2019 billing.
I. Background
Section 740 of the FD&C Act (21
U.S.C. 379j–12) establishes four
different types of user fees: (1) Fees for
certain types of animal drug
applications and supplements; (2)
annual fees for certain animal drug
products; (3) annual fees for certain
establishments where such products are
made; and (4) annual fees for certain
sponsors of animal drug applications
and/or investigational animal drug
submissions (21 U.S.C. 379j–12(a)).
When certain conditions are met, FDA
will waive or reduce fees (21 U.S.C.
379j–12(d)).
For FY 2019 through FY 2023, the
FD&C Act establishes aggregate yearly
base revenue amounts for each fiscal
year (21 U.S.C. 379j–12(b)(1)). Base
revenue amounts are subject to
adjustment for inflation and workload,
and for excess collections to reduce
workload-based increases or collection
shortfalls after FY 2020 (21 U.S.C. 379j–
12(c) and (g)). Fees for applications,
establishments, products, and sponsors
are to be established each year by FDA
so that the percentages of the total
revenue that are derived from each type
of user fee will be as follows: Revenue
from application fees shall be 20 percent
of total fee revenue; revenue from
product fees shall be 27 percent of total
fee revenue; revenue from establishment
fees shall be 26 percent of total fee
revenue; and revenue from sponsor fees
shall be 27 percent of total fee revenue
(21 U.S.C. 379j–12(b)(2)).
For FY 2020, the animal drug user fee
rates are: $440,446 for an animal drug
application; $220,223 for a
supplemental animal drug application
for which safety or effectiveness data are
required and for an animal drug
application subject to the criteria set
forth in section 512(d)(4) of the FD&C
Act (21 U.S.C. 360b(d)(4)); $11,353 for
an annual product fee; $159,177 for an
annual establishment fee; and $144,999
Dated: July 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16433 Filed 8–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3523]
Animal Drug User Fee Rates and
Payment Procedures for Fiscal Year
2020
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the fee rates and payment
procedures for fiscal year (FY) 2020
animal drug user fees. The Federal
Food, Drug, and Cosmetic Act (FD&C
Act), as amended by the Animal Drug
User Fee Amendments of 2018 (ADUFA
IV), authorizes FDA to collect user fees
for certain animal drug applications and
supplements, for certain animal drug
products, for certain establishments
where such products are made, and for
certain sponsors of such animal drug
applications and/or investigational
animal drug submissions. This notice
establishes the fee rates for FY 2020.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s website at https://www.fda.gov/
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SUMMARY:
for an annual sponsor fee. FDA will
issue invoices for FY 2020 product,
establishment, and sponsor fees by
December 31, 2019, and payment will
be due by January 31, 2020. The
application fee rates are effective for
applications submitted on or after
October 1, 2019, and will remain in
effect through September 30, 2020.
Applications will not be accepted for
review until FDA has received full
payment of application fees and any
other animal drug user fees owed under
the Animal Drug User Fee Act program
(ADUFA program).
II. Revenue Amount for FY 2020
A. Statutory Fee Revenue Amounts
ADUFA IV, Title I of Public Law 115–
234, specifies that the aggregate fee
revenue amount for FY 2020 for all
animal drug user fee categories is
$29,931,240 (21 U.S.C. 379j–
12(b)(1)(B)).
B. Inflation Adjustment to Fee Revenue
Amount
The fee revenue amounts established
in ADUFA IV for FY 2020 and
subsequent fiscal years are subject to an
inflation adjustment (21 U.S.C. 379j–
12(c)(2)).
ADUFA IV specifies that the annual
fee revenue amount is to be adjusted
using two separate adjustments—one for
personnel compensation and benefits
(PC&B) and one for non-PC&B costs (21
U.S.C. 379j–12(c)(2)(A)(ii) and (iii)). The
component of the inflation adjustment
for payroll costs shall be one plus the
average annual percent change in the
cost of all PC&B paid per full-time
equivalent (FTE) position at FDA for the
first 3 of the 4 preceding fiscal years,
multiplied by the average proportion of
PC&B costs to total FDA costs for the
first 3 of the 4 preceding fiscal years.
The data on total PC&B paid and
numbers of FTE paid, from which the
average cost per FTE can be derived, are
published in FDA’s Justification of
Estimates for Appropriations
Committees.
Table 1 summarizes that actual cost
and FTE data for the specified fiscal
years and provides the percent change
from the previous fiscal year and the
average percent change over the first 3
of the 4 fiscal years preceding FY 2020.
The 3-year average is 3.1175 percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
Fiscal year
2016
Total PC&B ..............................................................................
Total FTE .................................................................................
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$2,414,728,159
16,381
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2017
$2,581,551,000
17,022
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2018
$2,690,678,000
17,023
02AUN1
3-Year average
..............................
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TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE—Continued
Fiscal year
2016
PC&B per FTE .........................................................................
Percent Change from Previous Year ......................................
The statute specifies that this 3.1175
percent should be multiplied by the
2017
$147,408
2.2474%
2018
$151,660
2.8845%
proportion of PC&B costs to total FDA
costs. Table 2 shows the amount of
$158,061
4.2206%
3-Year average
..............................
3.1175%
PC&B and the total amount obligated by
FDA for the same 3 years.
TABLE 2—PC&B AS A PERCENT OF TOTAL COSTS AT FDA
Fiscal year
2016
Total PC&B ..............................................................................
Total Costs ...............................................................................
PC&B Percent ..........................................................................
The portion of the inflation
adjustment relating to payroll costs is
3.1175 percent multiplied by 50.8064
percent (or 1.5839 percent).
The statute specifies that the portion
of the inflation adjustment for nonpayroll costs is the average annual
percent change that occurred in the
Consumer Price Index (CPI) for urban
consumers (Washington-Baltimore, DCMD-VA-WV; not seasonally adjusted; all
items less food and energy; annual
index) for the first 3 of the preceding 4
$2,414,728,159
$4,666,236,000
51.7490%
2017
2018
$2,581,551,000
$5,104,580,000
50.5732%
years of available data multiplied by the
proportion of all costs other than PC&B
costs to total FDA costs. As a result of
a geographical revision made by the
Bureau of Labor and Statistics in
January 2018,1 the ‘‘WashingtonBaltimore, DC-MD-VA-WV’’ index was
discontinued and replaced with two
separate indices (i.e., ‘‘WashingtonArlington-Alexandria, DC-VA-MD-WV’’
and ‘‘Baltimore-Columbia-Towson,
MD’’). In order to continue applying a
CPI that best reflects the geographic
$2,690,678,000
$5,370,935,000
50.0970%
3-Year average
..............................
..............................
50.8064%
region in which FDA is headquartered
and which provides the most current
data available, the WashingtonArlington-Alexandria less food and
energy index will be used in calculating
the relevant adjustment factors for FY
2020 and subsequent years. Table 3
provides the summary data for the
percent change in the specified CPI for
the Washington-Arlington-Alexandria
area. The data from the Bureau of Labor
Statistics is shown in table 3.
TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN WASHINGTON-ARLINGTON-ALEXANDRIA AREA CPI LESS
FOOD AND ENERGY
Year
2016
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Annual CPI ...............................................................................
Annual Percent Change ..........................................................
To calculate the inflation adjustment
for non-payroll costs, we multiply the
1.3957 percent by the proportion of all
costs other than PC&B to total FDA
costs. Since 50.8064 percent was
obligated for PC&B as shown in table 2,
49.1936 percent is the portion of costs
other than PC&B (100 percent ¥
50.8064 percent = 49.1936 percent). The
portion of the inflation adjustment
relating to non-payroll costs is 1.3957
percent times 49.1936 percent, or 0.6866
percent.
Next, we add the payroll component
(1.5839 percent) to the non-payroll
component (0.6866 percent), for a total
inflation adjustment of 2.2705 percent,
and then add one, making 1.022705. We
then multiply the base revenue amount
for FY 2020 ($29,931,240) by 1.022705,
yielding an inflation adjusted amount of
$30,611,000 (rounded to the nearest
thousand dollars) for FY 2020.
2017
265.333
1.5306%
2018
266.897
0.5894%
C. Workload Adjustment to Inflation
Adjusted Fee Revenue Amount
The fee revenue amounts established
in ADUFA IV for FY 2020 and
subsequent fiscal years are also subject
to adjustment to account for changes in
FDA’s review workload. A workload
adjustment will be applied to the
inflation adjusted fee revenue amount
(21 U.S.C. 379j–12(c)(3)).
To determine whether a workload
adjustment applies, FDA calculates the
weighted average of the change in the
total number of each of the five types of
applications and submissions specified
in the workload adjustment provision
(animal drug applications, supplemental
animal drug applications for which data
with respect to safety or efficacy are
required, manufacturing supplemental
animal drug applications,
investigational animal drug study
submissions, and investigational animal
272.414
2.0671%
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..............................
1.3957%
drug protocol submissions) received
over the 5-year period that ended on
September 30, 2018 (the base years), and
the average number of each of these
types of applications and submissions
over the most recent 5-year period that
ended May 31, 2019.
The results of these calculations are
presented in the first two columns of
table 4. Column 3 reflects the percent
change in workload over the two 5-year
periods. Column 4 shows the weighting
factor for each type of application,
reflecting how much of the total FDA
animal drug review workload was
accounted for by each type of
application or submission in the table
during the most recent 5 years. Column
5 is the weighted percent change in each
category of workload, and was derived
by multiplying the weighting factor in
each line in column 4 by the percent
change from the base years in column 3.
1 https://www.bls.gov/cpi/additional-resources/
geographic-revision-2018.htm.
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3-Year average
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At the bottom right of the table the sum
of the values in column 5 is added,
reflecting a total change in workload of
0.99 percent for FY 2020. This is the
workload adjuster for FY 2020.
TABLE 4—WORKLOAD ADJUSTER CALCULATION
Application type
Column 1
5-Year
average
(base years)
Column 2
latest
5-Year
average
Column 3
percent
change
Column 4
weighting
factor
New Animal Drug Applications (NADAs) .............................
Supplemental NADAs with Safety or Efficacy Data ............
Manufacturing Supplements ................................................
Investigational Study Submissions ......................................
Investigational Protocol Submissions ..................................
FY 2020 ADUFA IV Workload Adjuster ...............................
16.4
11.6
353.2
183.2
236.4
........................
15.4
11.0
355.6
177.8
268.4
........................
¥6.0976%
¥5.1724%
0.6795%
¥2.9476%
13.5364%
........................
0.0444
0.0224
0.1556
0.5612
0.2164
........................
Under no circumstances will the
workload adjustment result in fee
revenues that are less than the base fee
revenues for that fiscal year as adjusted
for inflation (21 U.S.C. 379j–12(c)(3)).
FDA will not adjust the FY 2020 fee
revenue amount for workload changes
because the workload adjuster was less
than 1 percent.2
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D. Reduction of Workload-Based
Increase by Amount of Certain Excess
Collections
Under section 740(c)(3)(B) of the
FD&C Act, for fiscal years 2021 through
2023, if application of the workload
adjustment increases the amount of fee
revenues established for the fiscal year,
as adjusted for inflation, the fee revenue
increase will be reduced by the amount
of any excess collections for the second
preceding fiscal year, up to the amount
of the fee revenue increase. This
provision will not take effect until FY
2021.
E. Recovery of Collection Shortfalls
Under section 740(g)(5)(A) of the
FD&C Act, for FY 2021, the amount of
fees otherwise authorized to be
collected shall be increased by the
amount, if any, by which the amount
collected and appropriated for FY 2019
falls below the amount of fees
authorized for FY 2019. For FY 2022,
the amount of fees otherwise authorized
to be collected shall be increased by the
amount, if any, by which the amount
collected and appropriated for FY 2020
falls below the amount of fees
authorized for FY 2020. For FY 2023,
the amount of fees otherwise authorized
to be collected shall be increased by the
cumulative amount, if any, by which the
amount collected and appropriated for
fiscal years 2021 and 2022 (including
estimated collections for FY 2022) falls
2 CVM increases the fee revenue amount
established for the fiscal year to reflect changes in
workload only if the workload adjuster is equal to
or greater than 1 percent (1%).
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below the cumulative amount of fees
authorized for those 2 fiscal years.
Because the recovery of collection
shortfalls does not take effect until FY
2021, FDA will not adjust the FY 2020
fee revenue amount for the recovery of
collection shortfalls.
F. Reduction of Shortfall-Based Fee
Increase by Prior Year Excess
Collections
Under section 740(g)(5)(B) of the
FD&C Act, where FDA’s calculations
under section 740(g)(5)(A) result in an
increase for that fiscal year to recover a
collection shortfall, FDA must reduce
the increase by the amount of any
excess collections for preceding fiscal
years (after fiscal year 2018) that have
not already been applied for purposes of
reducing workload-based fee increases.
Because the recovery of collection
shortfalls does not take effect until FY
2021, FDA will not adjust the FY 2020
fee revenue amount for the reduction of
shortfall-based fee increases by prior
year excess collections.
G. FY 2020 Fee Revenue Amounts
ADUFA IV specifies that the revenue
amount of $30,611,000 (rounded to the
nearest thousand dollars) for FY 2020 is
to be divided as follows: 20 percent, or
a total of $6,122,200, is to come from
application fees; 27 percent, or a total of
$8,264,970, is to come from product
fees; 26 percent, or a total of $7,958,860,
is to come from establishment fees; and
27 percent, or a total of $8,264,970, is
to come from sponsor fees (21 U.S.C.
379j–12(b)).
III. Application Fee Calculations for
FY2020
A. Application Fee Revenues and
Numbers of Fee-Paying Applications
Each person who submits an animal
drug application or a supplemental
animal drug application shall be subject
to an application fee, with limited
exceptions (see 21 U.S.C. 379j–12(a)(1)).
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Column 5
weighted
percent
change
¥0.2705%
¥0.1161%
0.1057%
¥1.6542%
2.9297%
0.9946%
The term ‘‘animal drug application’’
means an application for approval of
any new animal drug submitted under
section 512(b)(1) of the FD&C Act or an
application for conditional approval of
a new animal drug submitted under
section 571 of the FD&C Act (21 U.S.C.
360ccc) (see section 739(1) of the FD&C
Act (21 U.S.C. 379j–11(1))). As the
expanded definition of ‘‘animal drug
application’’ includes applications for
conditional approval submitted under
section 571 of the FD&C Act, such
applications are now subject to ADUFA
fees, except that fees may be waived if
the drug is intended solely to provide
for a minor use or minor species
(MUMS) indication (see 21 U.S.C. 379j–
12(d)(1)(D)).
Prior to ADUFA IV, FDA only had
authority to grant conditional approval
for drugs intended for a MUMS
indication. Under amendments made to
section 571 of the FD&C Act by ADUFA
IV, FDA retains authority to grant
conditional approval for drugs intended
for MUMS indications but also will be
able to grant conditional approval for
certain drugs not intended for a MUMS
indication provided certain criteria are
met. Beginning with FY 2019, ADUFA
IV provides an exception from
application fees for animal drug
applications submitted under section
512(b)(1) of the FD&C Act if the
application is submitted by a sponsor
who previously applied for conditional
approval under section 571 of the FD&C
Act for the same product and paid an
application fee at the time they applied
for conditional approval. The purpose of
this exception is to prevent sponsors of
conditionally approved products from
having to pay a second application fee
at the time they apply for full approval
of their products under section 512(b)(1)
of the FD&C Act, provided the sponsor’s
application for full approval is filed
consistent with the timeframes
established in section 571(h) of the
FD&C Act.
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A ‘‘supplemental animal drug
application’’ is defined as a request to
the Secretary of Health and Human
Services (Secretary) to approve a change
in an animal drug application that has
been approved, or a request to the
Secretary to approve a change to an
application approved under section
512(c)(2) of the FD&C Act for which
data with respect to safety or
effectiveness are required (21 U.S.C.
379j–11(2)). The application fees are to
be set so that they will generate
$6,122,200 in fee revenue for FY 2020.
The fee for a supplemental animal drug
application for which safety or
effectiveness data are required and for
an animal drug application subject to
criteria set forth in section 512(d)(4) of
the FD&C Act is to be set at 50 percent
of the animal drug application fee (21
U.S.C. 379j–12(a)(1)(A)(ii)).
To set animal drug application fees
and supplemental animal drug
application fees to realize $6,122,200,
FDA must first make some assumptions
about the number of fee-paying
applications and supplements the
Agency will receive in FY 2020.
The Agency knows the number of
applications that have been submitted
in previous years, which fluctuates
annually. In estimating the fee revenue
to be generated by animal drug
application fees in FY 2020, FDA is
assuming that the number of
applications for which fees will be paid
in FY 2020 will equal the average
number of submissions over the 5 most
recent completed fiscal years of the
ADUFA program (FY 2014 to FY 2018).
Over the 5 most recent completed
fiscal years, the average number of
animal drug applications that would
have been subject to the full fee was 7.6.
Over this same period, the average
number of supplemental applications
for which safety or effectiveness data are
required and applications subject to the
criteria set forth in section 512(d)(4) of
the FD&C Act that would have been
subject to half of the full fee was 12.6.
B. Application Fee Rates for FY 2020
FDA must set the fee rates for FY 2020
so that the estimated 7.6 applications for
which the full fee will be paid and the
estimated 12.6 supplemental
applications for which safety or
effectiveness data are required and
applications subject to the criteria set
forth in section 512(d)(4) of the FD&C
Act for which half of the full fee will be
paid will generate a total of $6,122,200.
To generate this amount, the fee for an
animal drug application, rounded to the
nearest dollar, will have to be $440,446,
and the fee for a supplemental animal
drug application for which safety or
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effectiveness data are required and for
applications subject to the criteria set
forth in section 512(d)(4) of the FD&C
Act will have to be $220,223.
IV. Product Fee Calculations for FY
2020
A. Product Fee Revenues and Numbers
of Fee-Paying Products
The animal drug product fee must be
paid annually by the person named as
the applicant in a new animal drug
application or supplemental new animal
drug application for an animal drug
product submitted for listing under
section 510 of the FD&C Act (21 U.S.C.
360) and who had an animal drug
application or supplemental animal
drug application pending at FDA after
September 1, 2003 (21 U.S.C. 379j–
12(a)(2)). The term ‘‘animal drug
product’’ means each specific strength
or potency of a particular active
ingredient or ingredients in final dosage
form marketed by a particular
manufacturer or distributor, which is
uniquely identified by the labeler code
and product code portions of the
national drug code, and for which an
animal drug application or a
supplemental animal drug application
has been approved (21 U.S.C. 379j–
11(3)). The product fees are to be set so
that they will generate $8,264,970 in fee
revenue for FY 2020.
To set animal drug product fees to
realize $8,264,970, FDA must make
some assumptions about the number of
products for which these fees will be
paid in FY 2020. FDA developed data
on all animal drug products that have
been submitted for listing under section
510 of the FD&C Act and matched this
to the list of all persons who had an
animal drug application or supplement
pending after September 1, 2003. As of
June 2019, FDA estimates that there are
a total of 743 products submitted for
listing by persons who had an animal
drug application or supplemental
animal drug application pending after
September 1, 2003. Based on this, FDA
estimates that a total of 743 products
will be subject to this fee in FY 2020.
In estimating the fee revenue to be
generated by animal drug product fees
in FY 2020, FDA is assuming that 2
percent of the products invoiced, or 15,
will not pay fees in FY 2020 due to fee
waivers and reductions. FDA has made
this estimate at 2 percent this year,
based on historical data over the past 5
completed fiscal years of the ADUFA
program.
Accordingly, the Agency estimates
that a total of 728 (743 minus 15)
products will be subject to product fees
in FY 2020.
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37899
B. Product Fee Rates for FY 2020
FDA must set the fee rates for FY 2020
so that the estimated 728 products that
pay fees will generate a total of
$8,264,970. To generate this amount
will require the fee for an animal drug
product, rounded to the nearest dollar,
to be $11,353.
V. Establishment Fee Calculations for
FY 2020
A. Establishment Fee Revenues and
Numbers of Fee-Paying Establishments
The animal drug establishment fee
must be paid annually by the person
who: (1) Owns or operates, directly or
through an affiliate, an animal drug
establishment; (2) is named as the
applicant in an animal drug application
or supplemental animal drug
application for an animal drug product
submitted for listing under section 510
of the FD&C Act; (3) had an animal drug
application or supplemental animal
drug application pending at FDA after
September 1, 2003; and (4) whose
establishment engaged in the
manufacture of the animal drug product
during the fiscal year (see 21 U.S.C.
379j–12(a)(3)). An establishment subject
to animal drug establishment fees is
assessed only one such fee per fiscal
year. The term ‘‘animal drug
establishment’’ is defined as a foreign or
domestic place of business at one
general physical location, consisting of
one or more buildings, all of which are
within 5 miles of each other, at which
one or more animal drug products are
manufactured in final dosage form (21
U.S.C. 379j–11(4)). The establishment
fees are to be set so that they will
generate $7,958,860 in fee revenue for
FY 2020.
To set animal drug establishment fees
to realize $7,958,860, FDA must make
some assumptions about the number of
establishments for which these fees will
be paid in FY 2020. FDA developed data
on all animal drug establishments and
matched this to the list of all persons
who had an animal drug application or
supplement pending after September 1,
2003. As of June 2019, FDA estimates
that there are a total of 55
establishments owned or operated by
persons who had an animal drug
application or supplemental animal
drug application pending after
September 1, 2003. Based on this, FDA
believes that 55 establishments will be
subject to this fee in FY 2020.
In estimating the fee revenue to be
generated by animal drug establishment
fees in FY 2020, FDA is assuming that
9 percent of the establishments
invoiced, or 5, will not pay fees in FY
2020 due to fee waivers and reductions.
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FDA has made this estimate at 9 percent
this year, based on historical data over
the past 5 completed fiscal years.
Accordingly, the Agency estimates
that a total of 50 establishments (55
minus 5) will be subject to
establishment fees in FY 2020.
B. Establishment Fee Rates for FY 2020
FDA must set the fee rates for FY 2020
so that the fees paid for the estimated 50
establishments will generate a total of
$7,958,860. To generate this amount
will require the fee for an animal drug
establishment, rounded to the nearest
dollar, to be $159,177.
VI. Sponsor Fee Calculations for FY
2020
A. Sponsor Fee Revenues and Numbers
of Fee-Paying Sponsors
The animal drug sponsor fee must be
paid annually by each person who: (1)
Is named as the applicant in an animal
drug application, except for an
approved application for which all
subject products have been removed
from listing under section 510 of the
FD&C Act, or has submitted an
investigational animal drug submission
that has not been terminated or
otherwise rendered inactive and (2) had
an animal drug application,
supplemental animal drug application,
or investigational animal drug
submission pending at FDA after
September 1, 2003 (see 21 U.S.C. 379j–
11(6) and 379j–12(a)(4)). An animal
drug sponsor is subject to only one such
fee each fiscal year (see 21 U.S.C. 379j–
12(a)(4)). The sponsor fees are to be set
so that they will generate $8,264,970 in
fee revenue for FY 2020.
To set animal drug sponsor fees to
realize $8,264,970, FDA must make
some assumptions about the number of
sponsors who will pay these fees in FY
2020. FDA estimates that a total of 177
sponsors will meet this definition in FY
2020.
In estimating the fee revenue to be
generated by animal drug sponsor fees
in FY 2020, FDA is assuming that 68
percent of the sponsors invoiced, or 120,
will not pay sponsor fees in FY 2020
due to fee waivers and reductions. FDA
has made this estimate at 68 percent this
year, based on historical data over the
past 5 completed fiscal years of the
ADUFA program.
Accordingly, the Agency estimates
that a total of 57 sponsors (177 minus
120) will be subject to and pay sponsor
fees in FY 2020.
B. Sponsor Fee Rates for FY 2020
FDA must set the fee rates for FY 2020
so that the estimated 57 sponsors that
pay fees will generate a total of
$8,264,970. To generate this amount
will require the fee for an animal drug
sponsor, rounded to the nearest dollar,
to be $144,999.
VII. Fee Schedule for FY 2020
The fee rates for FY 2020 are
summarized in table 5.
TABLE 5—FY 2020 FEE RATES
Fee rate for
FY 2020
Animal drug user fee category
Animal Drug Application Fees:
Animal Drug Application ...............................................................................................................................................................
Supplemental Animal Drug Application for Which Safety or Effectiveness Data are Required or Animal Drug Application
Subject to the Criteria Set Forth in Section 512(d)(4) of the FD&C Act ..................................................................................
Animal Drug Product Fee ....................................................................................................................................................................
Animal Drug Establishment Fee 1 ........................................................................................................................................................
Animal Drug Sponsor Fee 2 .................................................................................................................................................................
1 An
2 An
220,223
11,353
159,177
144,999
animal drug establishment is subject to only one such fee each fiscal year.
animal drug sponsor is subject to only one such fee each fiscal year.
VIII. Fee Waiver or Reduction;
Exemption From Fees
A. Barrier to Innovation Waivers
jbell on DSK3GLQ082PROD with NOTICES
$440,446
Under section 740(d)(1)(A) of the
FD&C Act, an animal drug applicant
may qualify for a waiver or reduction of
one or more ADUFA fees if the fee
would present a significant barrier to
innovation because of limited resources
available to the applicant or due to other
circumstances. FDA CVM’s guidance for
industry (GFI) #170, entitled ‘‘Animal
Drug User Fees and Fee Waivers and
Reductions,’’ 3 states that for purposes of
determining whether to grant a barrier
to innovation waiver or reduction of
ADUFA fees on financial grounds, FDA
has determined an applicant with
financial resources of less than
$20,000,000 (including the financial
resources of the applicant’s affiliates),
3 .CVM’s GFI #170 is located at: https://
www.fda.gov/downloads/AnimalVeterinary/
GuidanceComplianceEnforcement/Guidancefor
Industry/UCM052494.pdf.
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18:02 Aug 01, 2019
Jkt 247001
adjusted annually for inflation, has
limited resources available. Using the
CPI for urban consumers (U.S. city
average; not seasonally adjusted; all
items; annual index), the inflationadjusted level for FY 2020 will be
$21,265,320; this level represents the
financial resource ceiling that will be
used to determine if there are limited
resources available to an applicant
requesting a barrier to innovation
waiver on financial grounds for FY 2020
in addition to the criteria requiring the
product to be innovative.
B. Exemptions From Fees
The types of fee waivers and
reductions that applied in ADUFA III
still exist for FY 2020. However, two
new exemptions and one new exception
from fees were established by ADUFA
IV, as follows:
If an animal drug application,
supplemental animal drug application,
or investigational submission involves
the intentional genomic alteration of an
animal that is intended to produce a
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
human medical product, any person
who is the named applicant or sponsor
of that application or submission will
not be subject to sponsor, product, or
establishment fees under ADUFA based
solely on that application or submission
(21 U.S.C. 379j–12(d)(4)(B)).
Fees will not apply to any person who
not later than September 30, 2023,
submits to CVM a supplemental animal
drug application relating to a new
animal drug application approved under
section 512 of the FD&C Act, solely to
add the application number to the
labeling of the drug in the manner
specified in section 502(w)(3) of the
FD&C Act (21 U.S.C. 352(w)(3)), if that
person otherwise would be subject to
user fees under ADUFA based only on
the submission of the supplemental
application (21 U.S.C. 379j–12(d)(4)(A)).
There is also an exception from
application fees for animal drug
applications submitted under section
512(b)(1) of the FD&C Act if the
application is submitted by a sponsor
who previously applied for conditional
E:\FR\FM\02AUN1.SGM
02AUN1
Federal Register / Vol. 84, No. 149 / Friday, August 2, 2019 / Notices
approval under section 571 of the FD&C
Act for the same product and paid an
application fee at the time they applied
for conditional approval, provided the
sponsor has submitted the application
under section 512(b)(1) of the FD&C Act
within the timeframe specified in
section 571(h) of the FD&C Act.
jbell on DSK3GLQ082PROD with NOTICES
IX. Procedures for Paying the FY 2020
Fees
A. Application Fees and Payment
Instructions
The appropriate application fee
established in the new fee schedule
must be paid for an animal drug
application or supplement subject to
fees under ADUFA IV that is submitted
on or after October 1, 2019. The
payment must be made in U.S. currency
by one of the following methods: Wire
transfer, electronic check, bank draft, or
U.S. postal money order made payable
to FDA. The preferred payment method
is online using electronic check
(Automated Clearing House (ACH) also
known as eCheck) or credit card
(Discover, VISA, MasterCard, American
Express). Secure electronic payments
can be submitted using the User Fees
Payment Portal at https://
userfees.fda.gov/pay, or the Pay.gov
payment option is available after you
submit a cover sheet. (Note: Only full
payments are accepted. No partial
payments can be made online.) Once
you search for and find your invoice,
select ‘‘Pay Now’’ to be redirected to
https://www.pay.gov/. Electronic
payment options are based on the
balance due. Payment by credit card is
available only for balances that are less
than $25,000. If the balance exceeds this
amount, only the ACH option is
available. Payments must be made using
U.S. bank accounts as well as U.S. credit
cards.
When paying by check, bank draft, or
U.S. postal money order, please write
your application’s unique Payment
Identification Number (PIN), beginning
with the letters AD, on the upper righthand corner of your completed Animal
Drug User Fee Cover Sheet. Also write
the FDA post office box number (P.O.
Box 979033) on the enclosed check,
bank draft, or money order. Mail the
payment and a copy of the completed
Animal Drug User Fee Cover Sheet to:
Food and Drug Administration, P.O.
Box 979033, St. Louis, MO 63197–9000.
When paying by wire transfer, the
invoice number needs to be included.
Without the invoice number, the
payment may not be applied. If the
payment amount is not applied, the
invoice amount would be referred to
collections. The originating financial
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18:02 Aug 01, 2019
Jkt 247001
institution may charge a wire transfer
fee. If the financial institution charges a
wire transfer fee, it is required to add
that amount to the payment to ensure
that the invoice is paid in full.
Use the following account
information when sending a payment by
wire transfer: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, FDA deposit
account number: 75060099, U.S.
Department of the Treasury routing/
transit number: 021030004, SWIFT
number: FRNYUS33.
To send a check by a courier such as
Federal Express, the courier must
deliver the check and printed copy of
the cover sheet to: U.S. Bank, Attn:
Government Lockbox 979033, 1005
Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier
delivery only. If you have any questions
concerning courier delivery, contact
U.S. Bank at 314–418–4013. This
telephone number is only for questions
about courier delivery.)
It is important that the fee arrives at
the bank at least a day or two before the
application arrives at CVM. FDA records
the official application receipt date as
the later of the following: The date the
application was received by CVM, or the
date U.S. Bank notifies FDA that your
payment in the full amount has been
received, or when the U.S. Treasury
notifies FDA of receipt of an electronic
or wire transfer payment. U.S. Bank and
the U.S. Treasury are required to notify
FDA within 1 working day, using the
PIN described previously.
FDA’s tax identification number is
53–0196965. (Note: In no case should
the payment for the fee be submitted to
FDA with the application.)
B. Application Cover Sheet Procedures
Step One—Create a user account and
password. Log on to the ADUFA website
at https://www.fda.gov/industry/animaldrug-user-fee-act-adufa/animal-druguser-fee-cover-sheet and, under
Application Submission Information,
click ‘‘Create ADUFA User Fee Cover
Sheet.’’ For security reasons, each firm
submitting an application will be
assigned an organization identification
number, and each user will also be
required to set up a user account and
password the first time they use this
site. Online instructions will walk you
through this process.
Step Two—Create an Animal Drug
User Fee Cover Sheet, transmit it to
FDA, and print a copy. After logging
into your account with user name and
password, complete the steps required
to create an Animal Drug User Fee
Cover Sheet. One cover sheet is needed
for each animal drug application or
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Frm 00077
Fmt 4703
Sfmt 4703
37901
supplement. Once you are satisfied that
the data on the cover sheet are accurate
and you have finalized the cover sheet,
you will be able to transmit it
electronically to FDA and you will be
able to print a copy of your cover sheet
showing your unique PIN.
Step Three—Send the payment for
your application as described in section
IX.A of this document.
Step Four—Please submit your
application and a copy of the completed
Animal Drug User Fee Cover Sheet to
the following address: Food and Drug
Administration, Center for Veterinary
Medicine, Document Control Unit
(HFV–199), 7500 Standish Pl.,
Rockville, MD 20855.
C. Product, Establishment, and Sponsor
Fees
By December 31, 2019, FDA will issue
invoices and payment instructions for
product, establishment, and sponsor
fees for FY 2020 using this fee schedule.
Payment will be due by January 31,
2020. FDA will issue invoices in
November 2020 for any products,
establishments, and sponsors subject to
fees for FY 2020 that qualify for fees
after the December 2019 billing.
Dated: July 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16434 Filed 8–1–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice To Announce Supplemental
Awards To Support Technical
Assistance To Address the HIV
Epidemic
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice to announce
supplemental awards to support
technical assistance to address the HIV
epidemic.
AGENCY:
HRSA provided supplemental
grant funds to two currently funded
National Training and Technical
Assistance Cooperative Agreement
award recipients to support ending the
HIV epidemic by providing critical
expertise and resources to health centers
in geographic locations identified in
Ending the HIV Epidemic: A Plan for
America.
FOR FURTHER INFORMATION CONTACT:
Tracey Orloff, Strategic Partnerships
SUMMARY:
E:\FR\FM\02AUN1.SGM
02AUN1
]]>Agencies
[Federal Register Volume 84, Number 149 (Friday, August 2, 2019)]
[Notices]
[Pages 37896-37901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16434]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3523]
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year
2020
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the fee rates and payment procedures for fiscal year (FY)
2020 animal drug user fees. The Federal Food, Drug, and Cosmetic Act
(FD&C Act), as amended by the Animal Drug User Fee Amendments of 2018
(ADUFA IV), authorizes FDA to collect user fees for certain animal drug
applications and supplements, for certain animal drug products, for
certain establishments where such products are made, and for certain
sponsors of such animal drug applications and/or investigational animal
drug submissions. This notice establishes the fee rates for FY 2020.
FOR FURTHER INFORMATION CONTACT: Visit FDA's website at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm
or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-
402-6888, [email protected]. For general questions, you may also
email the Center for Veterinary Medicine (CVM) at:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 740 of the FD&C Act (21 U.S.C. 379j-12) establishes four
different types of user fees: (1) Fees for certain types of animal drug
applications and supplements; (2) annual fees for certain animal drug
products; (3) annual fees for certain establishments where such
products are made; and (4) annual fees for certain sponsors of animal
drug applications and/or investigational animal drug submissions (21
U.S.C. 379j-12(a)). When certain conditions are met, FDA will waive or
reduce fees (21 U.S.C. 379j-12(d)).
For FY 2019 through FY 2023, the FD&C Act establishes aggregate
yearly base revenue amounts for each fiscal year (21 U.S.C. 379j-
12(b)(1)). Base revenue amounts are subject to adjustment for inflation
and workload, and for excess collections to reduce workload-based
increases or collection shortfalls after FY 2020 (21 U.S.C. 379j-12(c)
and (g)). Fees for applications, establishments, products, and sponsors
are to be established each year by FDA so that the percentages of the
total revenue that are derived from each type of user fee will be as
follows: Revenue from application fees shall be 20 percent of total fee
revenue; revenue from product fees shall be 27 percent of total fee
revenue; revenue from establishment fees shall be 26 percent of total
fee revenue; and revenue from sponsor fees shall be 27 percent of total
fee revenue (21 U.S.C. 379j-12(b)(2)).
For FY 2020, the animal drug user fee rates are: $440,446 for an
animal drug application; $220,223 for a supplemental animal drug
application for which safety or effectiveness data are required and for
an animal drug application subject to the criteria set forth in section
512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)); $11,353 for an annual
product fee; $159,177 for an annual establishment fee; and $144,999 for
an annual sponsor fee. FDA will issue invoices for FY 2020 product,
establishment, and sponsor fees by December 31, 2019, and payment will
be due by January 31, 2020. The application fee rates are effective for
applications submitted on or after October 1, 2019, and will remain in
effect through September 30, 2020. Applications will not be accepted
for review until FDA has received full payment of application fees and
any other animal drug user fees owed under the Animal Drug User Fee Act
program (ADUFA program).
II. Revenue Amount for FY 2020
A. Statutory Fee Revenue Amounts
ADUFA IV, Title I of Public Law 115-234, specifies that the
aggregate fee revenue amount for FY 2020 for all animal drug user fee
categories is $29,931,240 (21 U.S.C. 379j-12(b)(1)(B)).
B. Inflation Adjustment to Fee Revenue Amount
The fee revenue amounts established in ADUFA IV for FY 2020 and
subsequent fiscal years are subject to an inflation adjustment (21
U.S.C. 379j-12(c)(2)).
ADUFA IV specifies that the annual fee revenue amount is to be
adjusted using two separate adjustments--one for personnel compensation
and benefits (PC&B) and one for non-PC&B costs (21 U.S.C. 379j-
12(c)(2)(A)(ii) and (iii)). The component of the inflation adjustment
for payroll costs shall be one plus the average annual percent change
in the cost of all PC&B paid per full-time equivalent (FTE) position at
FDA for the first 3 of the 4 preceding fiscal years, multiplied by the
average proportion of PC&B costs to total FDA costs for the first 3 of
the 4 preceding fiscal years. The data on total PC&B paid and numbers
of FTE paid, from which the average cost per FTE can be derived, are
published in FDA's Justification of Estimates for Appropriations
Committees.
Table 1 summarizes that actual cost and FTE data for the specified
fiscal years and provides the percent change from the previous fiscal
year and the average percent change over the first 3 of the 4 fiscal
years preceding FY 2020. The 3-year average is 3.1175 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
----------------------------------------------------------------------------------------------------------------
Fiscal year 2016 2017 2018 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $2,414,728,159 $2,581,551,000 $2,690,678,000 .................
Total FTE........................... 16,381 17,022 17,023 .................
[[Page 37897]]
PC&B per FTE........................ $147,408 $151,660 $158,061 .................
Percent Change from Previous Year... 2.2474% 2.8845% 4.2206% 3.1175%
----------------------------------------------------------------------------------------------------------------
The statute specifies that this 3.1175 percent should be multiplied
by the proportion of PC&B costs to total FDA costs. Table 2 shows the
amount of PC&B and the total amount obligated by FDA for the same 3
years.
Table 2--PC&B as a Percent of Total Costs at FDA
----------------------------------------------------------------------------------------------------------------
Fiscal year 2016 2017 2018 3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B.......................... $2,414,728,159 $2,581,551,000 $2,690,678,000 .................
Total Costs......................... $4,666,236,000 $5,104,580,000 $5,370,935,000 .................
PC&B Percent........................ 51.7490% 50.5732% 50.0970% 50.8064%
----------------------------------------------------------------------------------------------------------------
The portion of the inflation adjustment relating to payroll costs
is 3.1175 percent multiplied by 50.8064 percent (or 1.5839 percent).
The statute specifies that the portion of the inflation adjustment
for non-payroll costs is the average annual percent change that
occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items
less food and energy; annual index) for the first 3 of the preceding 4
years of available data multiplied by the proportion of all costs other
than PC&B costs to total FDA costs. As a result of a geographical
revision made by the Bureau of Labor and Statistics in January 2018,\1\
the ``Washington-Baltimore, DC-MD-VA-WV'' index was discontinued and
replaced with two separate indices (i.e., ``Washington-Arlington-
Alexandria, DC-VA-MD-WV'' and ``Baltimore-Columbia-Towson, MD''). In
order to continue applying a CPI that best reflects the geographic
region in which FDA is headquartered and which provides the most
current data available, the Washington-Arlington-Alexandria less food
and energy index will be used in calculating the relevant adjustment
factors for FY 2020 and subsequent years. Table 3 provides the summary
data for the percent change in the specified CPI for the Washington-
Arlington-Alexandria area. The data from the Bureau of Labor Statistics
is shown in table 3.
---------------------------------------------------------------------------
\1\ https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.
Table 3--Annual and 3-Year Average Percent Change in Washington-Arlington-Alexandria Area CPI Less Food and
Energy
----------------------------------------------------------------------------------------------------------------
Year 2016 2017 2018 3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI.......................... 265.333 266.897 272.414 .................
Annual Percent Change............... 1.5306% 0.5894% 2.0671% 1.3957%
----------------------------------------------------------------------------------------------------------------
To calculate the inflation adjustment for non-payroll costs, we
multiply the 1.3957 percent by the proportion of all costs other than
PC&B to total FDA costs. Since 50.8064 percent was obligated for PC&B
as shown in table 2, 49.1936 percent is the portion of costs other than
PC&B (100 percent - 50.8064 percent = 49.1936 percent). The portion of
the inflation adjustment relating to non-payroll costs is 1.3957
percent times 49.1936 percent, or 0.6866 percent.
Next, we add the payroll component (1.5839 percent) to the non-
payroll component (0.6866 percent), for a total inflation adjustment of
2.2705 percent, and then add one, making 1.022705. We then multiply the
base revenue amount for FY 2020 ($29,931,240) by 1.022705, yielding an
inflation adjusted amount of $30,611,000 (rounded to the nearest
thousand dollars) for FY 2020.
C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount
The fee revenue amounts established in ADUFA IV for FY 2020 and
subsequent fiscal years are also subject to adjustment to account for
changes in FDA's review workload. A workload adjustment will be applied
to the inflation adjusted fee revenue amount (21 U.S.C. 379j-12(c)(3)).
To determine whether a workload adjustment applies, FDA calculates
the weighted average of the change in the total number of each of the
five types of applications and submissions specified in the workload
adjustment provision (animal drug applications, supplemental animal
drug applications for which data with respect to safety or efficacy are
required, manufacturing supplemental animal drug applications,
investigational animal drug study submissions, and investigational
animal drug protocol submissions) received over the 5-year period that
ended on September 30, 2018 (the base years), and the average number of
each of these types of applications and submissions over the most
recent 5-year period that ended May 31, 2019.
The results of these calculations are presented in the first two
columns of table 4. Column 3 reflects the percent change in workload
over the two 5-year periods. Column 4 shows the weighting factor for
each type of application, reflecting how much of the total FDA animal
drug review workload was accounted for by each type of application or
submission in the table during the most recent 5 years. Column 5 is the
weighted percent change in each category of workload, and was derived
by multiplying the weighting factor in each line in column 4 by the
percent change from the base years in column 3.
[[Page 37898]]
At the bottom right of the table the sum of the values in column 5 is
added, reflecting a total change in workload of 0.99 percent for FY
2020. This is the workload adjuster for FY 2020.
Table 4--Workload Adjuster Calculation
----------------------------------------------------------------------------------------------------------------
Column 1 5- Column 2 Column 4 Column 5
Application type Year average latest 5-Year Column 3 weighting weighted
(base years) average percent change factor percent change
----------------------------------------------------------------------------------------------------------------
New Animal Drug Applications 16.4 15.4 -6.0976% 0.0444 -0.2705%
(NADAs)........................
Supplemental NADAs with Safety 11.6 11.0 -5.1724% 0.0224 -0.1161%
or Efficacy Data...............
Manufacturing Supplements....... 353.2 355.6 0.6795% 0.1556 0.1057%
Investigational Study 183.2 177.8 -2.9476% 0.5612 -1.6542%
Submissions....................
Investigational Protocol 236.4 268.4 13.5364% 0.2164 2.9297%
Submissions....................
FY 2020 ADUFA IV Workload .............. .............. .............. .............. 0.9946%
Adjuster.......................
----------------------------------------------------------------------------------------------------------------
Under no circumstances will the workload adjustment result in fee
revenues that are less than the base fee revenues for that fiscal year
as adjusted for inflation (21 U.S.C. 379j-12(c)(3)). FDA will not
adjust the FY 2020 fee revenue amount for workload changes because the
workload adjuster was less than 1 percent.\2\
---------------------------------------------------------------------------
\2\ CVM increases the fee revenue amount established for the
fiscal year to reflect changes in workload only if the workload
adjuster is equal to or greater than 1 percent (1%).
---------------------------------------------------------------------------
D. Reduction of Workload-Based Increase by Amount of Certain Excess
Collections
Under section 740(c)(3)(B) of the FD&C Act, for fiscal years 2021
through 2023, if application of the workload adjustment increases the
amount of fee revenues established for the fiscal year, as adjusted for
inflation, the fee revenue increase will be reduced by the amount of
any excess collections for the second preceding fiscal year, up to the
amount of the fee revenue increase. This provision will not take effect
until FY 2021.
E. Recovery of Collection Shortfalls
Under section 740(g)(5)(A) of the FD&C Act, for FY 2021, the amount
of fees otherwise authorized to be collected shall be increased by the
amount, if any, by which the amount collected and appropriated for FY
2019 falls below the amount of fees authorized for FY 2019. For FY
2022, the amount of fees otherwise authorized to be collected shall be
increased by the amount, if any, by which the amount collected and
appropriated for FY 2020 falls below the amount of fees authorized for
FY 2020. For FY 2023, the amount of fees otherwise authorized to be
collected shall be increased by the cumulative amount, if any, by which
the amount collected and appropriated for fiscal years 2021 and 2022
(including estimated collections for FY 2022) falls below the
cumulative amount of fees authorized for those 2 fiscal years. Because
the recovery of collection shortfalls does not take effect until FY
2021, FDA will not adjust the FY 2020 fee revenue amount for the
recovery of collection shortfalls.
F. Reduction of Shortfall-Based Fee Increase by Prior Year Excess
Collections
Under section 740(g)(5)(B) of the FD&C Act, where FDA's
calculations under section 740(g)(5)(A) result in an increase for that
fiscal year to recover a collection shortfall, FDA must reduce the
increase by the amount of any excess collections for preceding fiscal
years (after fiscal year 2018) that have not already been applied for
purposes of reducing workload-based fee increases. Because the recovery
of collection shortfalls does not take effect until FY 2021, FDA will
not adjust the FY 2020 fee revenue amount for the reduction of
shortfall-based fee increases by prior year excess collections.
G. FY 2020 Fee Revenue Amounts
ADUFA IV specifies that the revenue amount of $30,611,000 (rounded
to the nearest thousand dollars) for FY 2020 is to be divided as
follows: 20 percent, or a total of $6,122,200, is to come from
application fees; 27 percent, or a total of $8,264,970, is to come from
product fees; 26 percent, or a total of $7,958,860, is to come from
establishment fees; and 27 percent, or a total of $8,264,970, is to
come from sponsor fees (21 U.S.C. 379j-12(b)).
III. Application Fee Calculations for FY2020
A. Application Fee Revenues and Numbers of Fee-Paying Applications
Each person who submits an animal drug application or a
supplemental animal drug application shall be subject to an application
fee, with limited exceptions (see 21 U.S.C. 379j-12(a)(1)). The term
``animal drug application'' means an application for approval of any
new animal drug submitted under section 512(b)(1) of the FD&C Act or an
application for conditional approval of a new animal drug submitted
under section 571 of the FD&C Act (21 U.S.C. 360ccc) (see section
739(1) of the FD&C Act (21 U.S.C. 379j-11(1))). As the expanded
definition of ``animal drug application'' includes applications for
conditional approval submitted under section 571 of the FD&C Act, such
applications are now subject to ADUFA fees, except that fees may be
waived if the drug is intended solely to provide for a minor use or
minor species (MUMS) indication (see 21 U.S.C. 379j-12(d)(1)(D)).
Prior to ADUFA IV, FDA only had authority to grant conditional
approval for drugs intended for a MUMS indication. Under amendments
made to section 571 of the FD&C Act by ADUFA IV, FDA retains authority
to grant conditional approval for drugs intended for MUMS indications
but also will be able to grant conditional approval for certain drugs
not intended for a MUMS indication provided certain criteria are met.
Beginning with FY 2019, ADUFA IV provides an exception from application
fees for animal drug applications submitted under section 512(b)(1) of
the FD&C Act if the application is submitted by a sponsor who
previously applied for conditional approval under section 571 of the
FD&C Act for the same product and paid an application fee at the time
they applied for conditional approval. The purpose of this exception is
to prevent sponsors of conditionally approved products from having to
pay a second application fee at the time they apply for full approval
of their products under section 512(b)(1) of the FD&C Act, provided the
sponsor's application for full approval is filed consistent with the
timeframes established in section 571(h) of the FD&C Act.
[[Page 37899]]
A ``supplemental animal drug application'' is defined as a request
to the Secretary of Health and Human Services (Secretary) to approve a
change in an animal drug application that has been approved, or a
request to the Secretary to approve a change to an application approved
under section 512(c)(2) of the FD&C Act for which data with respect to
safety or effectiveness are required (21 U.S.C. 379j-11(2)). The
application fees are to be set so that they will generate $6,122,200 in
fee revenue for FY 2020. The fee for a supplemental animal drug
application for which safety or effectiveness data are required and for
an animal drug application subject to criteria set forth in section
512(d)(4) of the FD&C Act is to be set at 50 percent of the animal drug
application fee (21 U.S.C. 379j-12(a)(1)(A)(ii)).
To set animal drug application fees and supplemental animal drug
application fees to realize $6,122,200, FDA must first make some
assumptions about the number of fee-paying applications and supplements
the Agency will receive in FY 2020.
The Agency knows the number of applications that have been
submitted in previous years, which fluctuates annually. In estimating
the fee revenue to be generated by animal drug application fees in FY
2020, FDA is assuming that the number of applications for which fees
will be paid in FY 2020 will equal the average number of submissions
over the 5 most recent completed fiscal years of the ADUFA program (FY
2014 to FY 2018).
Over the 5 most recent completed fiscal years, the average number
of animal drug applications that would have been subject to the full
fee was 7.6. Over this same period, the average number of supplemental
applications for which safety or effectiveness data are required and
applications subject to the criteria set forth in section 512(d)(4) of
the FD&C Act that would have been subject to half of the full fee was
12.6.
B. Application Fee Rates for FY 2020
FDA must set the fee rates for FY 2020 so that the estimated 7.6
applications for which the full fee will be paid and the estimated 12.6
supplemental applications for which safety or effectiveness data are
required and applications subject to the criteria set forth in section
512(d)(4) of the FD&C Act for which half of the full fee will be paid
will generate a total of $6,122,200. To generate this amount, the fee
for an animal drug application, rounded to the nearest dollar, will
have to be $440,446, and the fee for a supplemental animal drug
application for which safety or effectiveness data are required and for
applications subject to the criteria set forth in section 512(d)(4) of
the FD&C Act will have to be $220,223.
IV. Product Fee Calculations for FY 2020
A. Product Fee Revenues and Numbers of Fee-Paying Products
The animal drug product fee must be paid annually by the person
named as the applicant in a new animal drug application or supplemental
new animal drug application for an animal drug product submitted for
listing under section 510 of the FD&C Act (21 U.S.C. 360) and who had
an animal drug application or supplemental animal drug application
pending at FDA after September 1, 2003 (21 U.S.C. 379j-12(a)(2)). The
term ``animal drug product'' means each specific strength or potency of
a particular active ingredient or ingredients in final dosage form
marketed by a particular manufacturer or distributor, which is uniquely
identified by the labeler code and product code portions of the
national drug code, and for which an animal drug application or a
supplemental animal drug application has been approved (21 U.S.C. 379j-
11(3)). The product fees are to be set so that they will generate
$8,264,970 in fee revenue for FY 2020.
To set animal drug product fees to realize $8,264,970, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2020. FDA developed data on all animal drug products
that have been submitted for listing under section 510 of the FD&C Act
and matched this to the list of all persons who had an animal drug
application or supplement pending after September 1, 2003. As of June
2019, FDA estimates that there are a total of 743 products submitted
for listing by persons who had an animal drug application or
supplemental animal drug application pending after September 1, 2003.
Based on this, FDA estimates that a total of 743 products will be
subject to this fee in FY 2020.
In estimating the fee revenue to be generated by animal drug
product fees in FY 2020, FDA is assuming that 2 percent of the products
invoiced, or 15, will not pay fees in FY 2020 due to fee waivers and
reductions. FDA has made this estimate at 2 percent this year, based on
historical data over the past 5 completed fiscal years of the ADUFA
program.
Accordingly, the Agency estimates that a total of 728 (743 minus
15) products will be subject to product fees in FY 2020.
B. Product Fee Rates for FY 2020
FDA must set the fee rates for FY 2020 so that the estimated 728
products that pay fees will generate a total of $8,264,970. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest dollar, to be $11,353.
V. Establishment Fee Calculations for FY 2020
A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments
The animal drug establishment fee must be paid annually by the
person who: (1) Owns or operates, directly or through an affiliate, an
animal drug establishment; (2) is named as the applicant in an animal
drug application or supplemental animal drug application for an animal
drug product submitted for listing under section 510 of the FD&C Act;
(3) had an animal drug application or supplemental animal drug
application pending at FDA after September 1, 2003; and (4) whose
establishment engaged in the manufacture of the animal drug product
during the fiscal year (see 21 U.S.C. 379j-12(a)(3)). An establishment
subject to animal drug establishment fees is assessed only one such fee
per fiscal year. The term ``animal drug establishment'' is defined as a
foreign or domestic place of business at one general physical location,
consisting of one or more buildings, all of which are within 5 miles of
each other, at which one or more animal drug products are manufactured
in final dosage form (21 U.S.C. 379j-11(4)). The establishment fees are
to be set so that they will generate $7,958,860 in fee revenue for FY
2020.
To set animal drug establishment fees to realize $7,958,860, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2020. FDA developed data on all animal
drug establishments and matched this to the list of all persons who had
an animal drug application or supplement pending after September 1,
2003. As of June 2019, FDA estimates that there are a total of 55
establishments owned or operated by persons who had an animal drug
application or supplemental animal drug application pending after
September 1, 2003. Based on this, FDA believes that 55 establishments
will be subject to this fee in FY 2020.
In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2020, FDA is assuming that 9 percent of the
establishments invoiced, or 5, will not pay fees in FY 2020 due to fee
waivers and reductions.
[[Page 37900]]
FDA has made this estimate at 9 percent this year, based on historical
data over the past 5 completed fiscal years.
Accordingly, the Agency estimates that a total of 50 establishments
(55 minus 5) will be subject to establishment fees in FY 2020.
B. Establishment Fee Rates for FY 2020
FDA must set the fee rates for FY 2020 so that the fees paid for
the estimated 50 establishments will generate a total of $7,958,860. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest dollar, to be $159,177.
VI. Sponsor Fee Calculations for FY 2020
A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors
The animal drug sponsor fee must be paid annually by each person
who: (1) Is named as the applicant in an animal drug application,
except for an approved application for which all subject products have
been removed from listing under section 510 of the FD&C Act, or has
submitted an investigational animal drug submission that has not been
terminated or otherwise rendered inactive and (2) had an animal drug
application, supplemental animal drug application, or investigational
animal drug submission pending at FDA after September 1, 2003 (see 21
U.S.C. 379j-11(6) and 379j-12(a)(4)). An animal drug sponsor is subject
to only one such fee each fiscal year (see 21 U.S.C. 379j-12(a)(4)).
The sponsor fees are to be set so that they will generate $8,264,970 in
fee revenue for FY 2020.
To set animal drug sponsor fees to realize $8,264,970, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2020. FDA estimates that a total of 177 sponsors will meet
this definition in FY 2020.
In estimating the fee revenue to be generated by animal drug
sponsor fees in FY 2020, FDA is assuming that 68 percent of the
sponsors invoiced, or 120, will not pay sponsor fees in FY 2020 due to
fee waivers and reductions. FDA has made this estimate at 68 percent
this year, based on historical data over the past 5 completed fiscal
years of the ADUFA program.
Accordingly, the Agency estimates that a total of 57 sponsors (177
minus 120) will be subject to and pay sponsor fees in FY 2020.
B. Sponsor Fee Rates for FY 2020
FDA must set the fee rates for FY 2020 so that the estimated 57
sponsors that pay fees will generate a total of $8,264,970. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest dollar, to be $144,999.
VII. Fee Schedule for FY 2020
The fee rates for FY 2020 are summarized in table 5.
Table 5--FY 2020 Fee Rates
------------------------------------------------------------------------
Fee rate for
Animal drug user fee category FY 2020
------------------------------------------------------------------------
Animal Drug Application Fees:
Animal Drug Application............................. $440,446
Supplemental Animal Drug Application for Which 220,223
Safety or Effectiveness Data are Required or Animal
Drug Application Subject to the Criteria Set Forth
in Section 512(d)(4) of the FD&C Act...............
Animal Drug Product Fee................................. 11,353
Animal Drug Establishment Fee \1\....................... 159,177
Animal Drug Sponsor Fee \2\............................. 144,999
------------------------------------------------------------------------
\1\ An animal drug establishment is subject to only one such fee each
fiscal year.
\2\ An animal drug sponsor is subject to only one such fee each fiscal
year.
VIII. Fee Waiver or Reduction; Exemption From Fees
A. Barrier to Innovation Waivers
Under section 740(d)(1)(A) of the FD&C Act, an animal drug
applicant may qualify for a waiver or reduction of one or more ADUFA
fees if the fee would present a significant barrier to innovation
because of limited resources available to the applicant or due to other
circumstances. FDA CVM's guidance for industry (GFI) #170, entitled
``Animal Drug User Fees and Fee Waivers and Reductions,'' \3\ states
that for purposes of determining whether to grant a barrier to
innovation waiver or reduction of ADUFA fees on financial grounds, FDA
has determined an applicant with financial resources of less than
$20,000,000 (including the financial resources of the applicant's
affiliates), adjusted annually for inflation, has limited resources
available. Using the CPI for urban consumers (U.S. city average; not
seasonally adjusted; all items; annual index), the inflation-adjusted
level for FY 2020 will be $21,265,320; this level represents the
financial resource ceiling that will be used to determine if there are
limited resources available to an applicant requesting a barrier to
innovation waiver on financial grounds for FY 2020 in addition to the
criteria requiring the product to be innovative.
---------------------------------------------------------------------------
\3\ \.\CVM's GFI #170 is located at: https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052494.pdf.
---------------------------------------------------------------------------
B. Exemptions From Fees
The types of fee waivers and reductions that applied in ADUFA III
still exist for FY 2020. However, two new exemptions and one new
exception from fees were established by ADUFA IV, as follows:
If an animal drug application, supplemental animal drug
application, or investigational submission involves the intentional
genomic alteration of an animal that is intended to produce a human
medical product, any person who is the named applicant or sponsor of
that application or submission will not be subject to sponsor, product,
or establishment fees under ADUFA based solely on that application or
submission (21 U.S.C. 379j-12(d)(4)(B)).
Fees will not apply to any person who not later than September 30,
2023, submits to CVM a supplemental animal drug application relating to
a new animal drug application approved under section 512 of the FD&C
Act, solely to add the application number to the labeling of the drug
in the manner specified in section 502(w)(3) of the FD&C Act (21 U.S.C.
352(w)(3)), if that person otherwise would be subject to user fees
under ADUFA based only on the submission of the supplemental
application (21 U.S.C. 379j-12(d)(4)(A)).
There is also an exception from application fees for animal drug
applications submitted under section 512(b)(1) of the FD&C Act if the
application is submitted by a sponsor who previously applied for
conditional
[[Page 37901]]
approval under section 571 of the FD&C Act for the same product and
paid an application fee at the time they applied for conditional
approval, provided the sponsor has submitted the application under
section 512(b)(1) of the FD&C Act within the timeframe specified in
section 571(h) of the FD&C Act.
IX. Procedures for Paying the FY 2020 Fees
A. Application Fees and Payment Instructions
The appropriate application fee established in the new fee schedule
must be paid for an animal drug application or supplement subject to
fees under ADUFA IV that is submitted on or after October 1, 2019. The
payment must be made in U.S. currency by one of the following methods:
Wire transfer, electronic check, bank draft, or U.S. postal money order
made payable to FDA. The preferred payment method is online using
electronic check (Automated Clearing House (ACH) also known as eCheck)
or credit card (Discover, VISA, MasterCard, American Express). Secure
electronic payments can be submitted using the User Fees Payment Portal
at https://userfees.fda.gov/pay, or the Pay.gov payment option is
available after you submit a cover sheet. (Note: Only full payments are
accepted. No partial payments can be made online.) Once you search for
and find your invoice, select ``Pay Now'' to be redirected to https://www.pay.gov/. Electronic payment options are based on the balance due.
Payment by credit card is available only for balances that are less
than $25,000. If the balance exceeds this amount, only the ACH option
is available. Payments must be made using U.S. bank accounts as well as
U.S. credit cards.
When paying by check, bank draft, or U.S. postal money order,
please write your application's unique Payment Identification Number
(PIN), beginning with the letters AD, on the upper right-hand corner of
your completed Animal Drug User Fee Cover Sheet. Also write the FDA
post office box number (P.O. Box 979033) on the enclosed check, bank
draft, or money order. Mail the payment and a copy of the completed
Animal Drug User Fee Cover Sheet to: Food and Drug Administration, P.O.
Box 979033, St. Louis, MO 63197-9000. When paying by wire transfer, the
invoice number needs to be included. Without the invoice number, the
payment may not be applied. If the payment amount is not applied, the
invoice amount would be referred to collections. The originating
financial institution may charge a wire transfer fee. If the financial
institution charges a wire transfer fee, it is required to add that
amount to the payment to ensure that the invoice is paid in full.
Use the following account information when sending a payment by
wire transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty
St., New York, NY 10045, FDA deposit account number: 75060099, U.S.
Department of the Treasury routing/transit number: 021030004, SWIFT
number: FRNYUS33.
To send a check by a courier such as Federal Express, the courier
must deliver the check and printed copy of the cover sheet to: U.S.
Bank, Attn: Government Lockbox 979033, 1005 Convention Plaza, St.
Louis, MO 63101. (Note: This address is for courier delivery only. If
you have any questions concerning courier delivery, contact U.S. Bank
at 314-418-4013. This telephone number is only for questions about
courier delivery.)
It is important that the fee arrives at the bank at least a day or
two before the application arrives at CVM. FDA records the official
application receipt date as the later of the following: The date the
application was received by CVM, or the date U.S. Bank notifies FDA
that your payment in the full amount has been received, or when the
U.S. Treasury notifies FDA of receipt of an electronic or wire transfer
payment. U.S. Bank and the U.S. Treasury are required to notify FDA
within 1 working day, using the PIN described previously.
FDA's tax identification number is 53-0196965. (Note: In no case
should the payment for the fee be submitted to FDA with the
application.)
B. Application Cover Sheet Procedures
Step One--Create a user account and password. Log on to the ADUFA
website at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/animal-drug-user-fee-cover-sheet and, under Application Submission
Information, click ``Create ADUFA User Fee Cover Sheet.'' For security
reasons, each firm submitting an application will be assigned an
organization identification number, and each user will also be required
to set up a user account and password the first time they use this
site. Online instructions will walk you through this process.
Step Two--Create an Animal Drug User Fee Cover Sheet, transmit it
to FDA, and print a copy. After logging into your account with user
name and password, complete the steps required to create an Animal Drug
User Fee Cover Sheet. One cover sheet is needed for each animal drug
application or supplement. Once you are satisfied that the data on the
cover sheet are accurate and you have finalized the cover sheet, you
will be able to transmit it electronically to FDA and you will be able
to print a copy of your cover sheet showing your unique PIN.
Step Three--Send the payment for your application as described in
section IX.A of this document.
Step Four--Please submit your application and a copy of the
completed Animal Drug User Fee Cover Sheet to the following address:
Food and Drug Administration, Center for Veterinary Medicine, Document
Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855.
C. Product, Establishment, and Sponsor Fees
By December 31, 2019, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2020
using this fee schedule. Payment will be due by January 31, 2020. FDA
will issue invoices in November 2020 for any products, establishments,
and sponsors subject to fees for FY 2020 that qualify for fees after
the December 2019 billing.
Dated: July 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16434 Filed 8-1-19; 8:45 am]
BILLING CODE 4164-01-P
